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Senior Clinical Project Manager
2 weeks ago
- The Sr. Clinical Project Manager is responsible for managing Clinical Operations activities and providing functional supervision for Clinical Operations staff within their assigned Clinical Development Plan (CDP) as determined by the Director of Clinical Operations. The CPD conducts required tasks in collaboration with Clinical Project Management, Clinical Site Management and the Clinical Operations Specialist as well as with other members of the cross-functional CDP Project Teams.
- Responsible for representing Clinical Operations at the CDP level and for managing Clinical Operations activities as assigned with an entrepreneurial approach that requires the ability to multi-task on a wide spectrum of activities with an overall external focus.
- To perform this job successfully, an individual must be able to perform the following within the scope of their assigned Clinical Development Plan:
- Oversee clinical project and site management activities including: trial timelines, budgets, resources and vendors.
- Coordinates and drives clinical Project development strategy and process activities within a clinical Project
- Develops solutions to complex issues that require a high degree of ingenuity, creativity, and innovation.
- Identifies and helps resolve resource constraints and/or conflicts that affect multiple projects within a Project.
- Identifies and mitigates risk activities within a Project.
- Interacts with senior leadership and major stakeholders to establish strategic plans and objectives for Projects and project
- Coordinates activities between Clinical Operations and sponsor to ensure the timely execution of clinical trials within Projects
- Ensures all projects have timelines and project teams have clear goals, objectives, and milestones consistent with KlinEra objectives and financial goals. Participates in portfolio review and budget process.
- Facilitates team level decision-making and escalates key decisions.
- Ensures that effective collaboration and communication takes place across the organization.
- Effectively communicates project/Project strategy, status, critical path activity timing, resource requirements, and risks, both internally and to collaborators, as appropriate;
- Requires understanding and application of principles, practices, and standards that govern the industry
- Supervise Clinical Project Managers (CPMs) and Clinical Site Managers (CSMs) as assigned in collaboration with the Director of Clinical Operations (DCO). Assign short to mid-term responsibilities. Identify training needs to foster high level of performance, support career.
- Proactively manage performances issues. Establish key performance indicators in alignment with department and company objectives.
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Teams (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Determine Clinical Operations FTEs required efficiently executing clinical trials and provide regular updates and recommendations to DCO regarding resource management.
- Support the DCO in the development of the annual Clinical Operations budget and hiring plan.
- Ensure potential study risks are escalated to the attention of the DCO when appropriate.
- Develop and implement training and supporting operational documentation in collaboration with the DCO (SOPs, tools, etc.) for CPMs and CSMs.
- Develop clearly defined strategies and lead or contribute to assigned global, cross-functional interdisciplinary, high priority initiatives and process improvements.
- Cooperate across all relevant business units and maintain effective working relationships with interfacing groups.
